Literature DB >> 31744326

The Need to Change Regulatory Evaluation of Hypoglycemia in Trials of Diabetes Treatments.

David C Klonoff1, Alexander Fleming2, Robert Gabbay3.   

Abstract

Entities:  

Keywords:  FDA; clinical trial; diabetes; drug; hypoglycemia

Year:  2019        PMID： 31744326      PMCID： PMC7645132          DOI： 10.1177/1932296819891036

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN： 1932-2968


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  10 in total

1.  Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes.

Authors:  Rozalina G McCoy; Kasia J Lipska; Xiaoxi Yao; Joseph S Ross; Victor M Montori; Nilay D Shah
Journal:  JAMA Intern Med       Date:  2016-07-01       Impact factor: 21.873

2.  Economic impact of severe and non-severe hypoglycemia in patients with Type 1 and Type 2 diabetes in the United States.

Authors:  Volker Foos; Nebibe Varol; Bradley H Curtis; Kristina S Boye; David Grant; James L Palmer; Phil McEwan
Journal:  J Med Econ       Date:  2015-02-11       Impact factor: 2.448

Review 3.  Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes.

Authors: 
Journal:  Diabetes Care       Date:  2016-11-21       Impact factor: 19.112

4.  National estimates of insulin-related hypoglycemia and errors leading to emergency department visits and hospitalizations.

Authors:  Andrew I Geller; Nadine Shehab; Maribeth C Lovegrove; Scott R Kegler; Kelly N Weidenbach; Gina J Ryan; Daniel S Budnitz
Journal:  JAMA Intern Med       Date:  2014-05       Impact factor: 21.873

5.  Hypoglycemia evaluation and reporting in diabetes: Importance for the development of new therapies.

Authors:  David C Klonoff; G Alexander Fleming; Douglas B Muchmore; Brian M Frier
Journal:  Diabetes Metab Res Rev       Date:  2017-03-07       Impact factor: 4.876

Review 6.  Management of hypoglycemia in older adults with type 2 diabetes.

Authors:  Jeffrey Freeman
Journal:  Postgrad Med       Date:  2019-02-26       Impact factor: 3.840

7.  C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21-22 October 2001.

Authors:  Jerry P Palmer; G Alexander Fleming; Carla J Greenbaum; Kevan C Herold; Lisa D Jansa; Hubert Kolb; John M Lachin; Kenneth S Polonsky; Paolo Pozzilli; Jay S Skyler; Michael W Steffes
Journal:  Diabetes       Date:  2004-01       Impact factor: 9.461

8.  The burden of severe hypoglycemia in type 2 diabetes.

Authors:  Jieruo Liu; Rosa Wang; Michael L Ganz; Yurek Paprocki; Doron Schneider; James Weatherall
Journal:  Curr Med Res Opin       Date:  2017-11-13       Impact factor: 2.580

9.  Association of hypoglycaemia severity with clinical, patient-reported and economic outcomes in US patients with type 2 diabetes using basal insulin.

Authors:  Luigi F Meneghini; Lulu K Lee; Shaloo Gupta; Ron Preblick
Journal:  Diabetes Obes Metab       Date:  2018-02-07       Impact factor: 6.577

10.  Redefining Hypoglycemia in Clinical Trials: Validation of Definitions Recently Adopted by the American Diabetes Association/European Association for the Study of Diabetes.

Authors:  Simon R Heller; John B Buse; Robert Ratner; Elizabeth Seaquist; Lars Bardtrum; Charlotte Thim Hansen; Deniz Tutkunkardas; Alan C Moses
Journal:  Diabetes Care       Date:  2019-10-28       Impact factor: 17.152
  10 in total

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